Document control

ISO 17025 has the requirement for your laboratory to control documents and records. There are a number of reasons. Document control is not just about the unique identifiers (document name, number) and revision number. The purpose of document control is that plus to make sure the correct documents are in use, obsolete version are taken out of use. Furthermore to make sure all documents are reviewed periodically and have been approved.

If the form has been reviewed as suitable and you are meeting the other requirements, it is up to your laboratory to make a decision about the risk of hand written changes. You should document what you are allowing in your document control and record procedure to manage the risk – so that everyone understands what is and what is not allowed. Remember a form (blank template) is a document. Make sure the old form and number is in your record “List of Internal Documents” and you indicate teh old number as obsolete. Then create /renumber the form electronically and approve it.  Add it to the “List of Internal Documents”. Lastly, any handwritten changes should follow your procedure and should only be done by an authorised person with a neat line through the old number (so that it is still legible). Write, stamp or print the new number and initials of the authorised person on the preprinted "old" copies.

For more information on document control, see the ISO 17025 toolkit document template: Document and Record Control Procedure https://advisera.com/17025academy/documentation/document-and-record-control-procedure/